Comparison Between a Standard Tube and the Ultra-thin Tritube for Intubation of the Trachea and for Maintaining Access to the Trachea After Anaesthesia, in Patients With an Expected Difficult Direct Laryngoscopy
- Conditions
- Pharynx CancerOral NeoplasmLarynx Cancer
- Registration Number
- NCT03653039
- Lead Sponsor
- Michael Seltz Kristensen
- Brief Summary
The investigators compare the ease of intubation between a new ultra-thin endotracheal tube, "Tritube", and a standard endotracheal tube in patients with predictors of difficult laryngoscopy. Furthermore the investigators compare the acceptance of leaving the Tritube in trachea after end of anaesthesia, with the use of a tube exchange catheter.
- Detailed Description
In patients scheduled for surgery and anaesthesia in the Head-/neck/ear/nose/throat -region the investigators compare the ease of tracheal intubation between a new ultra-thin endotracheal tube, "Tritube", and a standard endotracheal tube in patients with predictors of difficult laryngoscopy. The intubation is performed with an angulated video laryngoscope.
Furthermore the investigators compare the acceptance of leaving the Tritube in trachea after end of anaesthesia, with the use of a tube exchange catheter. The latter continues into the post-operative recovery-ward.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Patients for anaesthesia for surgery in the Head-/neck/ear/nose/throat
- planned for oral intubation with video-laryngoscopy
- with risk factors for difficult direct laryngoscopy
- Patient with increased secretions in the airway (Pneumonia, bronchitis, productive cough)
- Patients planned for awake intubation
- Patients where mask-ventilation is judged to could become impossible
- Patients where access to the cricothyroid membrane is judged to be difficult or impossible
- Patients in ASA (american Society of Anaesthesiologists) physical classification status >3
- Patients who are scheduled for rapid sequence induction (RSI) due to risk of aspiration
- Patients with stridor
- Patients with hypoxemia (Saturation < 90 % in room air)
- Operation duration planned to > 2.5 hours
- Patients with the need for a nerve-stimulation-tube during surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of Excellent intubation conditions 2 hours Rate of Excellent intubation conditions judged on the scale excellent/good/fair/poor
- Secondary Outcome Measures
Name Time Method Number of intubation attempts 2 hours one attempt is every-time the tube is advanced past the incisors
the "percent of glottic opening" , (POGO), Before the tube is inserted 2 hours The surgeons score of the space and working conditions in the mouth/pharynx and larynx after intubation 2 hours The difference between ET CO2 and arterial blood-gas CO2 after 15 minutes of surgery 20 minutes The patient's satisfaction with having the Tritube or the tube-exchange-catheter in place when being awake in the Post anaesthesia care unit 4 hours Visual analog scale from 1-10, 1= no nuisance, 10= unberable
The rate of succesful intubation with 60 seconds 1 minute Number of remodellings of the stilette 2 hours rate of use for "reverse loading" of the tube on the stylet 2 hours Intubation conditions Strom scale 2 hours Direction of the tube-stylet combination excellent/good/poor, easy/fair/difficult. Advancement of the tube-stylet combination excellent/good/poor easy/fair/difficult
The ration of patients who still has the Tritube or the tube-exchange-catheter in place when arriving in the post-operative recovery unit 4 hours The Intubation Difficulty Score (IDS) 2 hours The intubation difficulty scale , range 0 to 7, 0 indicates easy intubation, 1 - 5 indicates slight difficulty, 5\< indicates moderate to major difficulty
the"percent of glottic opening" , POGO, with the tube in place 2 hors the duration of the Tritube being in the trachea after return of spontaneous ventilation and deflation of the cuff /(Tritube group) 4 hours The ration of patients who still has the Tritube or the tube-exchange-catheter in place one hour after arrival in the Post anaesthesia care unit the post-operative recovery unit 4 hours The rate of interruption by the tube of the view to the vocal cords at any time, to such a degree that it disturbs the intubation 2 hours Time to intubated 2 hours Time from the tube is advanced past the vocal cords until the cuff is inflated in the trachea
Time to the patient becomes ventilated via the tube 2 hours Time from the tube is advanced past the vocal cords until the cuff is inflated in the trachea and CO2 waveform is observed
The duration of the tube-exchange catheter being in the trachea after its placement / (Tube-exchange-catheter group) 4 hours
Trial Locations
- Locations (1)
Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
🇩🇰Copenhagen, Denmark
Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071🇩🇰Copenhagen, Denmark